Atramat
Atramat Nylon Surgical Suture Black USP 8-0 EP 0,4, 13 CM Needle E-SE-6.5 Supraglyde Premium Taper Point 6.5 MM 3/8 Circle Nylon Negro USP 8-0, 13 CM Aguja E-SE-6.5 Ahusada Premium…
Atramat Nylon Surgical Suture Black USP 8-0 EP 0,4, 13 CM Needle E-SE-6.5 Supraglyde Premium Taper Point 6.5 MM 3/8 Circle Nylon Negro USP 8-0, 13 CM Aguja E-SE-6.5 Ahusada Premium Supraglyde 6.5 MM 3/8 Circulo
3manufacturers in China registered for this device type
127catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (2), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
| Foosin Medical Supplies Inc.ltd | Weihai | Shandong | Manufacturer | 8 |
| ARC Medical Supplies (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
Record
| Listed by | Internacional Farmacéutica S.A DE C.V, Mexico |
|---|---|
| FDA product code | GAR |
| Device type | Suture, Nonabsorbable, Synthetic, Polyamide |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5020 |
| 510(k) | K905286 |
| Record published | 2018-07-12 |
| Record revised | 2021-02-05 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 15 to 30 °C; Storage environment humidity 0 to 65 % RH |
| Packaging | Dozen of 12, box with 24 packs of 24 |
| Sizes | Length 4 to 77 mm |
| Distribution end date | 2029-09-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 37 mm | In distribution |
| NYLON | Length 6 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 37 mm | In distribution |
| NYLON | Length 36 mm | In distribution |
| NYLON | Length 36 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 6.5 mm | In distribution |
| NYLON | 6.5 | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 60 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 37 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 36 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 12 mm | In distribution |
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 13 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 11 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 30 mm | In distribution |
| NYLON | Length 11 mm | In distribution |
| NYLON | Length 4 mm | In distribution |
| NYLON | Length 12 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 60 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 60 mm | In distribution |
| NYLON | In distribution | |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 7 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 13 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 6 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 5 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 11 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 60 mm | In distribution |
| NYLON | Length 13 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 37 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 60 mm | In distribution |
| NYLON | Length 37 mm | In distribution |
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 12 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 5 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 4 mm | In distribution |
| NYLON | Length 30 mm | In distribution |
| NYLON | Length 6 mm | In distribution |
| NYLON | Length 60 mm | In distribution |
| NYLON | Length 5 mm | In distribution |
| NYLON | Length 40 mm | In distribution |
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 6.5 mm | In distribution |
| NYLON | Length 40 mm | In distribution |
| NYLON | Length 4 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 6 mm | In distribution |
| NYLON | Length 13 mm | In distribution |
| NYLON | 60 | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 37 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | 26 | In distribution |
| NYLON | Length 37 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 6 mm | In distribution |
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 13 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 5 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 6 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 6 mm | In distribution |
| NYLON | Length 5 mm | In distribution |
| NYLON | Length 30 mm | In distribution |
| NYLON | Length 30 mm | In distribution |
| NYLON | Length 16 mm | In distribution |
| NYLON | Length 77 mm | In distribution |
| NYLON | Length 77 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 13 mm | In distribution |
| NYLON | Length 26 mm | In distribution |
| NYLON | Length 11 mm | In distribution |
| NYLON | 3/8 CIRCLE | In distribution |
| NYLON | Length 7 mm | In distribution |
| NYLON | Length 11 mm | In distribution |
| NYLON | Length 36 mm | In distribution |
| NYLON | Length 19 mm | In distribution |
| NYLON | Length 7 mm | In distribution |
| NYLON | Length 24 mm | In distribution |
| NYLON | Length 13 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DemeLON | Demetech Corp. | 1,800 |
| Dafilon | B Braun Surgical SA | 592 |
| WEGO-Nylon Non-absorbable Surgical Suture With Needle | Foosin Medical Supplies Inc.ltd | 279 |
| Ethilon | Ethicon, Inc. | 272 |
| Monosof | Covidien LP | 256 |
| DemeLON Multi | Demetech Corp. | 227 |
| Surgilon | Covidien LP | 135 |
| Supramid Extra | S. Jackson, Inc. | 119 |
| Mani Sutures Nylon | Mani, Inc. | 88 |
| Onatec | Surgical Specialties México, S. de R.L. de C.V. | 75 |
| Sharpoint Plus | Surgical Specialties México, S. de R.L. de C.V. | 73 |
| Trelon | B Braun Surgical SA | 72 |
Showing 12 of 284. All products under Suture, Nonabsorbable, Synthetic, Polyamide
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N85060 | 1988-02-22 | NONABSORBABLE SURG. SUTURES, NYLON | Deknatel, Inc. |
| N85316 | 1986-06-20 | ETHILON/NUROLON NYLON SUTURES | Ethicon, Inc. |
| N80838 | 1985-07-23 | SUPRAMID EXTRA SUTURES | S. Jackson, Inc. |
| N83511 | 1982-05-18 | NON-ABSORBABLE SUTURES NYLON | Davis & Geck, Inc. |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.